Job Description Summary Prihodnost je v naših rokah. / The future is ours to shape. Job Description #LI-Hybrid Na Brniku vzpostavljamo nov visokotehnološki center za proizvodnjo podobnih bioloških zdravil, v katerem bodo pomemben del tudi sodobni laboratoriji za kontrolo kakovosti. V novo QC ekipo vabimo Specialista kontrole kakovosti na področju vstopne kontrole, ki bo sodeloval pri vzpostavitvi novega laboratorija za kontrolo kakovosti vhodnih materialov ter uvajanju analitskih metod, opreme in procesov za prihodnje rutinsko GMP delovanje. V tej vlogi boste svoje analitsko in strokovno znanje povezovali z vzpostavljanjem novega laboratorijskega okolja, fizikalno-kemijskimi analizami ter zagotavljanjem regulatorne skladnosti in kakovosti. Vaše ključne odgovornosti: Sodelovanje pri vzpostavitvi novega laboratorija za kontrolo kakovosti vhodnih materialov, vključno z uvajanjem laboratorijske opreme in zagotavljanjem operativne pripravljenosti laboratorija. Zagotavljanje analitske in tehnične podpore pri uvajanju fizikalno-kemijskih analiznih metod ter aktivnosti vstopne kontrole komponent medicinskih pripomočkov. Koordinacija in podpora pri izvajanju IQ/OQ/PQ aktivnosti ter kvalifikaciji analitske opreme. Sodelovanje pri pripravi in vzdrževanju laboratorijske dokumentacije, vključno z navodili za delo, standardnimi operativnimi postopki (SOP) in drugo relevantno dokumentacijo. Sodelovanje pri uvajanju novih laboratorijskih informacijskih sistemov. Sodelovanje pri prenosih analitskih metod ter pregled in odobravanje rezultatov rutinskega testiranja čistih medijev in kemijskih analiz primarne ovojnine, kot so brizge in kartuše. Raziskava laboratorijskih dogodkov, vključno z odstopi, rezultati izven specifikacijskih mej in drugimi aktivnostmi, povezanimi z GMP. Vzdrževanje stalne pripravljenosti področja na regulatorne inšpekcijske preglede. Vaš prispevek k delovnemu mestu: Visokošolsko izobrazbo farmacevtske, kemijske ali druge naravoslovne smeri. Najmanj 2 leti delovnih izkušenj s področja kakovosti, razvoja, proizvodnje ali drugega ustreznega področja. Izkušnje s fizikalno-kemijskimi analiznimi metodami, laboratorijsko opremo ali kontrolo vhodnih materialov so prednost. Izkušnje s kvalifikacijo analitske opreme oziroma IQ/OQ/PQ aktivnostmi so prednost. Zaželeno poznavanje GMP okolja, laboratorijske dokumentacije in zahtev glede integritete podatkov. Aktivno znanje angleškega jezika. Poznavanje orodja Microsoft Office. Natančnost, odgovornost, analitičen način razmišljanja in sposobnost sodelovanja z različnimi strokovnimi ekipami. Kaj nudimo: Lokacija dela: Brnik (do odprtja obrata bo delo potekalo v Ljubljani) Vrsta pogodbe: pogodba za nedoločen čas s 6-mesečnim poskusnim obdobjem Predvideni tedenski delovni čas: 40 ur Plačni razpon (letna bruto plača): 30.960 – 46.440 EUR* Plača v Sandozu temelji na nivoju delovnega mesta, kvalifikacijah, specifičnih veščinah in znanjih ter delovnih izkušnjah. Visoko usposobljeni kandidati so običajno umeščeni okoli mediane plačnega razpona, manj izkušeni na spodnji del razpona, kandidati z izrazito močnimi ali nišnimi kompetencami pa višje. Pri umeščanju v plačni razpon upoštevamo tudi notranjo uravnoteženost plač in zunanje tržne podatke. Naš paket ugodnosti dodatno vključuje: Letni bonus (STI): odstotek letne plače. Regres za letni dopust: leta 2026 je znašal 2.450,00 EUR (neto). Božičnica: leta 2025 je znašala 2.100 EUR (bruto). OurShare: Vsako leto bo zaposleni v družbi Lek d.d. upravičen do prejema delnic družbe Sandoz AG. Prostovoljno dodatno pokojninsko zavarovanje: družba Lek d.d. v celoti krije mesečni prispevek za dodatno pokojninsko zavarovanje v višini 5,844 % vaše mesečne bruto plače (zgornja zneskovna omejitev je 3.224,18 EUR letno). Kolektivno življenjsko in nezgodno zavarovanje (kritje velja 24/7). Hibridno delovno okolje, ki omogoča fleksibilnost in možnost dela na daljavo. Ste pripravljeni na naslednji korak v karieri? Prijavo z življenjepisom v angleškem in slovenskem jeziku lahko oddate najpozneje do 26. novembra 2026.   Zakaj Sandoz? Sandoz je vodilni svetovni proizvajalec generičnih in podobnih bioloških zdravil – segmenta zdravstvene industrije, ki zagotavlja 80 % vseh zdravil na svetu po 30-odstotni ceni ter s tem vpliva na življenja več kot milijarde ljudi v več kot 100 državah. Čeprav smo ponosni na svoje dosežke, si prizadevamo narediti še več, da bi vsakdo imel dostop do temeljne človekove pravice – pravice do dobrega zdravja. Z naložbami v nove razvojne zmogljivosti, proizvodne lokacije, nove pridobitve in partnerstva imamo priložnost oblikovati prihodnost Sandoza ter še večjemu številu ljudi omogočiti trajnostni dostop do cenovno ugodnih in visokokakovostnih zdravil. Naš zagon temelji na odprti kulturi sodelovanja, katere srce so naši talentirani in ambiciozni sodelavci in sodelavke. V okolju, kjer so raznoliki načini razmišljanja dobrodošli in kjer se podpira osebna rast, imajo v zameno za uporabo svojih znanj možnost v celoti izkusiti delo v agilnem in povezovalnem okolju ter razvijati svojo uspešno kariero.  Pridružite se nam in nam pomagajte povečati pravičnost in hitrost zdravstvenega varstva. Prihodnost je v naših rokah. Predani smo raznolikosti in vključenosti: Zavzemamo se za raznolikost, enake možnosti in vključenost. Prizadevamo si za oblikovanje raznolikih timov, saj ti predstavljajo naše bolnike in skupnosti, ki jih oskrbujemo.  ------------------------------------------------------------------------------------------- At Brnik, we are establishing a new high-tech manufacturing center for biosimilars, which will include modern Quality Control laboratories as an integral part of the site. We are looking for a QC Specialist in Incoming Control to join our new QC team and contribute to the establishment of the new Incoming Materials Quality Control Laboratory, including the implementation of analytical methods, equipment, and processes for future routine GMP operations. In this role, you will combine your analytical and technical expertise with the establishment of a new laboratory environment, physicochemical testing, and activities supporting regulatory compliance and product and process quality. Your key responsibilities: Support the establishment and operational readiness of the new Incoming Materials Quality Control Laboratory, including laboratory equipment implementation. Provide analytical and technical support for the implementation of physicochemical testing methods and incoming control activities for medical device components. Coordinate and support IQ/OQ/PQ activities and qualification of analytical equipment. Support the preparation and maintenance of laboratory documentation, including working procedures, standard operating procedures (SOPs), and other relevant documentation. Support the implementation of new laboratory information systems. Support analytical method transfers and perform review and approval of routine testing results for clean media and chemical analysis of primary packaging, including syringes and cartridges. Investigate and manage laboratory events, including deviations, OOX results, and other GMP-related activities. Maintain ongoing inspection readiness within the assigned area of responsibility. What you will bring to the role: University degree in pharmacy, chemistry, or another natural science field. Minimum 2 years of working experience in quality, development, manufacturing, or another relevant field. Experience with physicochemical testing methods, analytical equipment, or incoming materials control is an advantage. Experience with analytical equipment qualification and IQ/OQ/PQ activities is an advantage. Knowledge of a GMP-regulated environment, laboratory documentation, and data integrity requirements is preferred. Functional knowledge of English. Knowledge of Microsoft Office. Accuracy, accountability, analytical thinking, and the ability to collaborate effectively across different expert teams. What we offer: Job location: Brnik (until the site opens, the position will be based in Ljubljana) Contract type: permanent contract with 6-month probation period Expected weekly working hours: 40 Pay range (annual gross salary): € 30.960 – 46.440 EUR* * Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data. Our compensation package additionally includes: Annual bonus (STI): percentage of annual salary Vacation allowance: in 2026 it was €2,450.00 net Christmas bonus: in 2025 it was €2,100 gross OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary Collective life and accident insurance (24/7 coverage) A hybrid work environment offering flexibility and remote work possibilities. Ready for your next career move? You are kindly invited to submit your application in English and Slovene, including a CV, by November 26th 2026.   Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health. With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues who, in return for applying their skills, experience an agile and collegiate environment where diversity of thought is welcomed and where personal growth is supported!  Join us in helping to make healthcare fairer and faster. The future is ours to shape. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve.     #Sandoz Skills Desired Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!

Specialist kontrole kakovosti – Vstopna kontrola (m/ž/d) / QC Specialist – Incoming Control (m/f/d).

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